This invention relates to packaging and more particularly to packaging of devices useful with medicament vials or the like.
A specific preferred example of a device of the type herein contemplated is disclosed in commonly assigned U.S. Pat. No. 4,768,568. This patent discloses a device in the form of a control assembly for use with a vial having a hazardous material therein and an open end sealingly closed by an elastomeric stopper assembly. The purpose of the control assembly is to enable a user to mix a diluent with the hazardous material within the vial and then fill a syringe having a hypodermic needle with the liquid solution in such a way as to substantially prevent the hazardous material from entering the immediate atmospheric environment. In the opening paragraphs of the specification of the aforesaid patent, there is discussion and identification of a number of devices of this type. The present invention contemplates packaging of any of the prior art devices of this type. However, a preferred device is the control assembly disclosed in the aforesaid patent.
The control assembly disclosed in the patent includes a hollow control structure having opposite first and second open ends. The first open end of the control structure is closed by a septum capable of having the syringe needle moved in penetrating relation therethrough and of providing a seal after the syringe needle has been withdrawn. The control structure is capable of being fixedly secured to the vial so that the second open end thereof is disposed in sealed relation to the stopper assembly end of the vial. A piston is mounted within the hollow interior of the control structure between the open ends dividing the hollow interior into a vented chamber communicating with the septum through the first open end and a sealed chamber communicating with the central exterior of the elastomeric stopper assembly of the vial through the second open end. The vented chamber is vented to the atmosphere and a filter is disposed in the vent so as to permit the vented chamber to remain at atmospheric conditions while preventing movement of hazardous material outwardly through the vent past the filter. The piston is mounted within the control structure for movement from an initial position wherein the volume of the vented chamber is maximum and the volume of the sealed chamber is minimum to a final position wherein the volume of the vented chamber is minimum and the volume of the sealed chamber is maximum. The central portion of the piston is formed of a resilient material in a size and shape sufficient to provide the capability of having the syringe needle which is first moved in penetrating relation through the septum thereafter moved in penetrating relation through the central portion of the piston and of providing a seal after the syringe needle has been withdrawn so that when the syringe needle after having been moved in penetrating relation successively through the septum and the piston is thereafter moved in penetrating relation through the elastomeric stopper of the vial, any elevated pressure conditions and aerosoling of hazardous material which passes outwardly of the elastomeric stopper incident to syringe needle withdrawal therefrom is captured within the sealed chamber and any elevated pressure conditions produced thereby are reduced substantially to atmospheric conditions by the increase of the volume of the seal chamber through movement of the piston from its initial position until the pressure causes the piston to reach its final position so that the subsequent withdrawal of the syringe needle from the piston occurs while the sealed chamber is generally under atmospheric conditions and, hence, no aerosoling of hazardous material into the vented chamber occurs incident to such withdrawal, thereby enabling the subsequent withdrawal of the syringe needle from the septum to occur under uncontaminated atmospheric pressure conditions within the vented chamber.
As disclosed in the patent, the device is particularly suited for use in situations where the diluent filling and mixing procedures are performed separately from the procedures relating to the filling of a syringe with the liquid solution. Typically, these functions are separately defined in a hospital situation where the dry medicament within the vial is, subsequently, mixed with diluent in the pharmacy and a different syringe is filled with the liquid solution prior to administration either in the ward or in the patient's room. Under these circumstances, while in the pharmacy it is desirable to equalize the pressure within the vial after the diluent has been inserted and mixed with the dry or freeze dried medicament. This pressure equalization is achieved simply by releasing the diluent syringe plunger with the end of the needle communicating within the upper portion of the interior of the vial confining the gaseous fluid therein above the liquid solution. The plunger will be displaced by the pressure. This will reduce the pressure within the vial substantially to atmospheric conditions. The needle of the syringe with the gaseous fluid filled therein is then withdrawn from the stopper assembly and piston so that the end of the needle is disposed within the vented chamber. The gaseous fluid contents of the diluent syringe chamber are then extruded through the needle into the vented chamber and finally the needle is withdrawn with the syringe chamber exhausted. Similarly, when the filling procedures are to be undertaken, it is preferable to first withdraw the plunger of the syringe and to expel the gaseous contents of the syringe chamber into the vial after the needle has been moved through the stopper assembly. This introduction of pressure into the vial chamber is then used to assist in moving the liquid solution back into the chamber of the syringe. This is accomplished by inverting the vial so that the open end of the needle penetrates just through the stopper assembly and the gaseous pressure on top of the liquid serves to move the same downwardly through the needle and into the syringe.
The device of the patent is thus effective in alleviating the possibility of hazardous material from entering the immediate environment. However, the device does not provide any protection against contamination of the environment in the event that the vial container itself should be accidentally fractured so as to spill the contents to the environment.